SANDIMMUN

This brand name is authorized in Austria, Australia, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

Active ingredients

The drug SANDIMMUN contains one active pharmaceutical ingredient (API):

1 Ciclosporin
UNII 83HN0GTJ6D - CYCLOSPORINE

Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide immunomodulator with immunosuppressant properties. It has been shown to prolong survival of allogeneic transplants in animals and significantly improved graft survival in all types of solid organ transplantation in man. Ciclosporin has also been shown to have an anti-inflammatory effect.

Read about Ciclosporin

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
SANDIMMUN Concentrate for solution for infusion Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
L04AD01 Ciclosporin L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AD Calcineurin inhibitors
Discover more medicines within L04AD01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 5631J, 6109M
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 526513301157311, 526513302153318, 526513402115310, 526513403138314, 526513404118317, 526513405114315
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 00042777, 00042783, 00165385, 00165391, 00165416, 00165422, 00165439, 00165445, 00424645, 00424668, 01593692, 01688613, 01688814, 01688843, 01895223, 01895246, 02560430, 03633148, 03633154, 04289233, 04680210, 04680227, 04680233, 04680256, 04781135, 04781141, 04781158, 04781164, 04964025, 04994670, 04994687, 04994693, 05392364, 05392370, 05392387, 05392393, 05392401, 05392418, 07669686, 08760064, 08763890, 08763909, 08763915, 08763921, 08763938, 08763944, 08775746, 08816304, 08816310, 08816327, 08816333, 08816356, 08816362, 08898874, 08898880, 08898897, 08898905, 09282419, 12638104, 16774761, 17448288, 17448294, 17848668, 17848674
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 20.241-1-08-02, 20.243-1-08-02
Country: EE Ravimiamet Identifier(s): 1008526, 1008548, 1008559, 1235135, 1693548, 1731855, 1787474, 1865279
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 56798, 56799, 56800, 60318, 60319, 60320
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 061937, 466482, 467563, 467720, 586107
Country: FR Base de données publique des médicaments Identifier(s): 62935801
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 23546, 23548, 23550, 27800, 27804, 34908
Country: HK Department of Health Drug Office Identifier(s): 20029, 38058, 38059, 38060, 38061, 51354
Country: IE Health Products Regulatory Authority Identifier(s): 88165, 88166, 88167, 88168, 88169
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 3005, 3006, 3007, 3008
Country: IT Agenzia del Farmaco Identifier(s): 029453014, 029453026, 029453038, 029453053
Country: JP 医薬品医療機器総合機構 Identifier(s): 3999004S1036, 3999406A1032
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1001739, 1001740, 1001741, 1090664, 1090665
Country: MT Medicines Authority Identifier(s): AA565/46501, MA1249/02701, MA1249/02702, MA1249/02703
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 099M84, 106M84, 223M90
Country: NG Registered Drug Product Database Identifier(s): 04-9672
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 3909, 3910, 3911, 3912, 3913, 3914
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100059881, 100059898, 100059906, 100059912, 100085223, 100247000
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W01231001, W51398001, W51399001
Country: SG Health Sciences Authority Identifier(s): 00520P, 08176P, 08177P, 08178P, 08179P, 09871P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 10283111H, 10283112H, 10283151H, 10283261H, 10283262H, 10283263H
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699504190007, 8699504190052, 8699504590005, 8699504760057
Country: ZA Health Products Regulatory Authority Identifier(s): 29/34/0056, 29/34/0058, 29/34/0059, 35/34/0132, Q/34/271, R/34/267

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